MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HORIZONTAL SPAR, HIP DISTRACTOR; APPARATUS, TRACTION, NON-POWERED

Catalog Number 3105000104

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that part of the procedure was postponed per the surgeon's decision.Please note there was no patient harm.

Event Description

It was reported that part of the procedure was postponed per the surgeon's decision.Please note there was no patient harm.

Manufacturer Narrative

This device was received at oem-wom for evaluation.Based on the oem-cmi investigation report attached, the reported failure ¿ locking in place issue¿ was confirmed.According to cmi: udi: (b)(4).Manufacturing date: 07/23/2019.Visual and functional inspection: h-006 hdf-a-bms horz - brake feet pop off ball (1 brake).Device identification: rma 222.Device history review: n/a.Investigation conclusion: issue is due to end user mishandling (transporting system with the brakes engaged).The design of this brake is very weak, so it can easily break with this type of misuse.Probable root cause: user handling, weak design.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: HORIZONTAL SPAR, HIP DISTRACTOR
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10782141
• MDR Text Key: 214517272
• Report Number: 0002936485-2020-00450
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3105000104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other